Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation (COMPHI)
Study to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost.
This pilot, non-interventional, company-sponsored, multi-center study documents observational data on patients under routine treatment of Pulmonary Arterial Hypertension (PAH) with inhaled iloprost (using I-Neb device for the inhalation).
The planned study recruitment time is 18 months. The maximum follow up period in this study will be 12 months.
The data will be collected from patients who have initiated the treatment mentioned above (inhaled iloprost using I-Neb device) since February 1st, 2013.
Frequency of visits and procedures will be performed under routine conditions. The primary objective of this study is to assess the compliance of patients with WHO/NYHA (World Health Organization/New York Heart Association) functional Class III Pulmonary Arterial Hypertension treated with Inhaled Iloprost in clinical practice, using the I-neb Insight tool.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Multiple Locations、ポルトガル
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Adult patients (age ≥ 18years old), male or female
- Diagnosis of Pulmonary Arterial Hypertension, Group I of the Dana Point Pulmonary Hypertension classification (Diagnosis made at the discretion of the attending investigator, including mPAP ≥ 25 mmHg at rest, as measured by right heart catheterization.)
- The treating physician has chosen to initiate the treatment with inhaled iloprost with I-Neb device for the application, as described in the Summary of Product characteristics (SmPC).
- WHO/NYHA functional class III
- Willing to participate in the study (Informed Consent Sign)
- Patients who received the first inhaled iloprost treatment with I-Neb from February 1st, 2013.
Exclusion Criteria:
- Any contraindication for the treatment with Ventavis as described in the Summary of Product characteristics (SmPC)
- Patients are not to be enrolled if they were treated with inhaled iloprost with I-Neb or any other device for the application in the past, before the start of the observation period (February 1st, 2013)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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グループ1
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Patients Diagnosed with Pulmonary Arterial Hypertension, Functional Class NYHA/WHO III, for whom was prescribed inhaled Iloprost.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of compliant patients
時間枠：Up to 12 months
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The compliance will be assessed by the mean daily number of Inhalations and mean daily dose of Ventavis at around months 6 and 12 for each patient (Data will be collected via the I-neb Insight).
For this observational study, a patient is considered compliant if the mean daily number of inhalations and mean daily dose are within 80 to 120% of prescribed.
Otherwise, the patient will be considered as non-compliant.
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Up to 12 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Observed treatment duration days
時間枠：Up to 12 months
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Up to 12 months
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Expected treatment duration days
時間枠：Up to 12 months
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Up to 12 months
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Changes in WHO/ NYHA Functional Class
時間枠：Up to 12 months
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Up to 12 months
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Change in 6 MWDT (6 minute walking distance test) scale value
時間枠：Up to 12 months
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Up to 12 months
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Change in Dyspnea Borg CR (category ratio) 10 scale value
時間枠：Up to 12 months
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Up to 12 months
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Quality of life using validated scales (EuroQol questionnaire [EQ-5D], Living with Pulmonary Hypertension questionnaire [LPH])
時間枠：Up to 12 months
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Up to 12 months
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Adjusted percentage treatment duration
時間枠：Up to 12 months
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Up to 12 months
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。